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Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR)

K222153 Class II Traditional
Decision Date
2023-02-03
Sponsor / Applicant
Microlife Intellectual Property GmbH

Technical Specification

510(k) Submission ID K222153
Product Code DXN
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.1130
Decision Date 2023-02-03
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR) received FDA 510(k) clearance under submission number K222153, sponsored by Microlife Intellectual Property GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2023-02-03.

Classification & Regulation

This clearance is catalogued under FDA product code DXN and 21 CFR 870.1130, within the Cardiovascular review panel as a Class II device.